Safety performance placebo effect

Andre et al. [36] recently reviewed the safety aspects of the controlled trials performed with the vaccines of a single manufacturer. Six hundred and ninety subjects were enrolled (347 active + 343 placebo), 218 of them children (103 active + 115 placebo). The large majority of events were mild. All events had similar incidence in active and placebo, with the exception of the oral and gastrointestinal side effects, which were more frequent in SLIT patients, although they were always mild. The occurrence of side effects and dropouts was similar in adults and children. 

Double-blind placebo-controlled studies of oral supplementation of creatine in human subjects have shown increased performance during short duration, strenuous, high-intensity exercise. Such activities require that ATP be replenished rapidly from phosphocreatine stores during anaerobic metabolism. These studies usually consisted of ingestion of 20 g of creatine per day for 5 days followed by a maintenance dose of 5-10 g/day. Studies on creatine as an ergogenic aid have not been uniformly positive some have shown no beneficial effect and still others have been equivocal and indicated that creatine supplementation did not enhance athletic activities. The safety issues of long-term creatine supplementation on kidney, liver, nerve, muscle, and other tissues are not known. 

Herberg (1993) reported a study that assessed the effects on safety of combining kava with ethanol. This was a double blind, placebo-controlled randomized trial of 40 healthy volunteers (ten males and ten females in each group), aged between 18 and 60 years (mean=4l years). The aim of the study was to test the adverse effects on seven safety-related performance variables when adult volunteers combine kava with acute intake of ethanol at a blood alcohol concentration of 0.05%. The battery of performance tests measured vigilance, coordination, reaction time, and concentration. One group received the kava extract WS 1490 alone, and the other group received the kava extract... 

Placebo-controlled studies Several multicenter placebo-controlled studies were performed to assess the efficacy and safety of perampanel [115-117 ], [118 ]. Both 8 mg/day and 12 mg/day doses were evaluated. The most common adverse effects attributed to the medication were dizziness, somnolence, headache, fatigue, falls, irritability, ataxia, and weight gain. All the symptoms except weight increase and irritability were thought to be dose-dependent. 

---